The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.

The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks.  That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court.  Another reason could be that the California Supreme Court’s opinion reaching for personal jurisdiction in BMS was so clearly swimming against the Supreme Court’s recent current that its reversal was widely anticipated and thus gained notoriety even faster than usual.  That last part is speculation, but still, we have not heard so much about personal jurisdiction since poor Mr. Burnham traveled from New Jersey to California to visit his kids. See Burnham v. Superior Court, 495 U.S. 604 (1990).

So what will we see following BMS?  We saw last week that some plaintiffs will try to stretch even the most tenuous forum contacts into specific jurisdiction, and some courts may go along with that.  We expect that most will not.  Take for example a recent opinion from the New Jersey Appellate Division, Dutch Run-Mays Draft, LCC v. Wolf Block, LLP, __ A.3d __, 2017 WL 2854420 (N.J. App. Div. July 5, 2017).  In Dutch Run, a Florida real estate developer sued a dissolved Pennsylvania law firm in New Jersey state court, and it argued that the law firm’s compliance with New Jersey’s business registration statute created personal jurisdiction “by consent.”  The New Jersey courts rejected that position.  Sure, the plaintiff was able to identify New Jersey contacts—business registration, a New Jersey registered agent, two New Jersey offices, the residency of some partners on the law firm’s dissolution committee, and three lawsuits that the law firm filed in New Jersey’s courts.

The problem for the plaintiff was that its claims had nothing to do with these New Jersey contacts. As the court put it, “[T]he negligence forming plaintiff’s cause of action did not arise from defendant’s contacts with New Jersey.  Plaintiff cannot show any relationship between the underlying matter and the business or attorneys in New Jersey.” Id. at *5.  Thus, no specific personal jurisdiction.  This is a faithful application of BMS, which requires a causal link between the defendant’s forum contacts and the plaintiff’s alleged injury.

Equally as important, the court held that the law firm’s registration in New Jersey did not imply “consent” to general personal jurisdiction under Daimler AG v. Bauman:

Plaintiff suggests Daimler’s holding is narrowed by its facts, specifically that Daimler was not registered as a foreign entity and had no registered agent or offices in California.

This limited view ignores Daimler’s definitive due process analysis. . . .  We now join the many courts that have circumscribed the view of general jurisdiction post-Daimler. . . .  In light of Daimler, we reject the application of [Allied-Signal, Inc. v. Purex Indus., Inc. 242 N.J. Super. 362 (App. Div. 1990)] as allowing general jurisdiction solely based on the fiction of implied consent by a foreign corporation’s compliance with New Jersey’s business registration statute. . . .  Importantly, the exercise of general jurisdiction requires satisfaction of the “continuous and systematic contacts” to comply with due process. Mere registration to conduct some business is insufficient.

Dutch Run, at *7 (emphasis added, citations omitted).  The court also rejected the plaintiff’s request for “jurisdictional discovery” because “[w]e remain unconvinced that permitting further discovery would have altered our conclusion.” Id. at *8.

Speaking of discovery, we also commend to you the order rejecting “jurisdictional discovery” in In re Baltimore City Asbestos Litigation (Smith v. Automotive Prods. Co.), Memorandum Opinion & Order, No. 24X13000333 (Baltimore City Circuit Ct. June 7, 2017).  In Smith, a Pennsylvania plaintiff sued multiple Pennsylvania defendants in Pennsylvania.  But after some defendants won summary judgment, the plaintiff tried to re-file his lawsuit in Maryland, which has a longer statute of limitations.  Slip op. at 2.

The Maryland court initially reserved ruling on personal jurisdiction and allowed limited “jurisdictional discovery.” This made neither side happy, resulting in dueling motions for reconsideration:  The defendants asked again for dismissal, and the plaintiffs wanted broader discovery.

The defendants won. Citing BMS, the court ruled that it lacked specific personal jurisdiction over the defendants because

this suit is unrelated to any alleged contact the Defendants may have had with the State of Maryland. Further the Defendants in this suit have conducted virtually no business in the State of Maryland and, therefore, have not purposefully availed themselves of the privilege of conducting activities in the State.  Therefore, this Court lacks specific jurisdiction over the Defendants in this suit.

Slip op. at 5. The court similarly lacked general personal jurisdiction over the defendants because they were not “at home” in Maryland, where “the only relevant inquiry is whether the defendant is either incorporated or has its principle place of business in the forum state.”  Slip op. at 6 (citing Daimler AG v. Bauman).  Like the New Jersey court in Dutch Run, the Maryland court rejected “jurisdictional discovery” because “[i]t is clear that further discovery will not uncover facts demonstrating the existence of general jurisdiction over any of the moving Defendants.  All of the Defendants are incorporated outside of Maryland.  The Defendants’ principal places of business are all in Europe.”  Slip op. at 6.

We bring you these two cases not only because they are timely, but because they confront tactics that we expect to see post-BMS—assertions of jurisdiction “by consent” and requests for “jurisdictional discovery.”  Our view on jurisdiction by consent is clear:  We don’t think it holds up; and as the New Jersey court found, a majority of courts have ruled that business registration alone does not form consent to jurisdiction.

As for discovery, these courts were correct to reject discovery where the facts already showed that jurisdiction was lacking. To this, we can add only that courts contemplating “jurisdictional discovery” should be reticent, very reticent.  As is commonly true with phased discovery, defining the phases can be challenging, leading to substantial overlap between discovery on jurisdictional facts versus discovery on all other facts.  It is a slippery slope toward full-blown discovery, in a case where the plaintiff has not yet established the court’s jurisdiction.  Look at what the plaintiff did in Smith v. Automotive Products, discussed above—the court gave them jurisdictional discovery, and their response was to ask for more.  We are not surprised.  Of course, this all assumes that a court has the power to allow discovery against a defendant contesting jurisdiction in the first place.  We don’t know the answer to that question, but the yet-to-be established nature of the court’s prerogative is another reason to tread lightly.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

We’ve talked a fair amount about forum shopping on this blog. Forum shopping is largely in the control of plaintiffs’ counsel because they, within reason, get to choose where to file their clients’ lawsuits. And since they do need some reason, there are several frequently used methods by plaintiffs’ counsel when they’ve narrowed in on the court they’ve decided would be most favorable for their clients – typically state court. If a plaintiff wants to stay in state court where he/she resides, he/she sues a non-diverse party. In drug and device cases, that’s usually a pharmacy, a sales representative, a doctor. Sometimes the joinder of such a defendant is fraudulent and the case becomes removal, sometimes not. Another option is to sue a defendant in state court where the defendant resides, a court from which the defendant cannot remove the case. While venue in that scenario may be proper, where the only connection to the jurisdiction is the presence of the defendant, defendants have met with mixed success in arguing forum non conveniens. Just think, if plaintiff lives in Nebraska, ingested the drug in Nebraska, suffered her injury in Nebraska, but files suit in New Jersey – where is most of the discovery that is needed located? Especially discovery from third-parties who will require subpoenas. What state’s law is likely to apply to the bulk of the claims?   Doesn’t make a lot of sense to be in New Jersey except for plaintiff’s preference to be in state court.

But what about when plaintiff’s choice of forum doesn’t turn out like he/she hoped? Should they get a do-over? A mulligan? A second chance? We don’t think so and neither did the court in Zarilli v. Johnson & Johnson, Docket No. ATL-L-1480-16, slip op. (N.J. Super. Law Div. Feb. 3, 2017). This case is one of several pending in New Jersey involving allegations of injury from the use of talc powder. The cases have been coordinated before a single judge for pre-trial proceedings. Plaintiff originally filed her suit in July 2016, and amended her complaint in September 2016. Defendants answered the complaint in October. Id. at 2.

Continue Reading Buyer Beware, No Buyer’s Remorse in New Jersey

Over the last couple of years, the Accutane mass tort in New Jersey state court has become the gift that keeps on giving.  The latest installment is a two-fer: In re Accutane Litigation, 2016 WL 5958374 (New Jersey Super. Law. Div. Oct. 12, 2016), and In re Accutane Litigation, 2016 WL 5958375 (New Jersey Super. Law. Div. Oct. 12, 2016).  Between these two orders, practically every permutation of causation under the learned intermediary rule is addressed, and the end result is the grant of summary judgment against an impressive 160 of 162 plaintiffs.

For obvious reasons, we’ll call the first (#374) “Accutane I” and the second (#375) “Accutane II” to tell them apart.

Eighty-six plaintiffs’ cases failed in Accutane I because they couldn’t even begin to satisfy their usual burden of proof.  That was because, by the time they got around to bringing their lawsuits, their prescribing physicians had either died (44 plaintiffs) or else simply could not be located (42 plaintiffs).  2016 WL 5958374, at *1-2.  As we’ve discussed before, in one of our “little lists” posts, there’s now quite a bit of law enforcing the burden of proof in dead/missing prescriber cases.  We even feel somewhat paternal feelings in this area, because several of your merry bloggers (Eric A, Steve M, and Bexis), litigated this issue extensively a decade ago in Diet Drug cases at a time when there was practically no directly on-point precedent.  In doing so, we increased the number of favorable decisions from one to seven.

Accutane I represents another giant step forward. The court held that, under the law of no fewer than 35 jurisdictions, a plaintiff who could not obtain any prescriber testimony at all could not meet his/her burden under the learned intermediary rule (now the law, as we’ve pointed out, of all fifty states) of establishing that the absent prescriber would have changed the relevant prescription had s/he received a supposedly “adequate” warning.  The defendant’s causation argument was rather basic:

Defendants argue that without the testimony of the deceased or missing physicians, Plaintiffs cannot establish that [the drug] would not have been prescribed given a different warning and thus they cannot satisfy proximate cause. Absent physicians’ testimony, Defendants argue that the causal link to injury is broken.  Even if the proximate cause standard were as Plaintiffs claim – that their prescriber might hypothetically have altered their risk discussion somehow if only [the manufacturer] had warned differently – Defendants assert that physician testimony is still needed.

2016 WL 5958374, at *3 (citation omitted). Plaintiffs fell back on that old canard, the “heeding presumption.” Id. at *4.  The court, however, was having none of it.

[T]he Court is persuaded by Defendants’ arguments that the heeding presumption within a learned intermediary context does not equate with a decision by the physician to not prescribe the drug.  If it did, medications would never be prescribed when accompanied by warnings because of the various risks associated with their use.

. . .Plaintiffs concede that their physicians are deceased or otherwise unavailable, and they have offered nothing by way of individual opposition papers. . . . Accordingly, the case-specific facts presented by Defendants are undisputed.

Plaintiffs’ reasoning is flawed, especially when one considers the slew of risks associated with and heeded by [prescription drug] users and prescribing physicians. Notably, application of the heeding presumption in the context of a pharmaceutical learned intermediary case where a manufacturer provided a warning and its adequacy remains in issue is not reflected within any of the cited case law.

Id. at 10-11 (citation omitted) (emphasis added).  Regardless of any presumption, all plaintiffs “still have the burden of proof for every element of their claim.”

Continue Reading Warning Causation Potpourri in New Jersey Mass Tort

The decision in Carl v. Johnson & Johnson, 2016 WL 4580145 (N.J. Super. Law, Sep. 2, 2016) is masterful. It is a well-researched, well-vetted, and well-written decimation of plaintiffs’ expert case. It is the type of Daubert opinion that defendants long for. It is lengthy and there is so much in it that is good, to cover it all we’d simply have to re-print the decision here. Which we won’t do. However, we strongly encourage you to read this decision. If you aren’t embroiled in an expert battle right now, bookmark this case and come back to it. The thoroughness and attention to detail by the court in the face of an obvious lack of those things by plaintiffs and their experts makes this a real page-turner.

The decision actually was entered in two cases, both brought by women who were diagnosed with ovarian cancer who in these lawsuits allege their cancer was caused by their use of powder containing talc. Defendants filed motions challenging all five of plaintiffs’ experts and moved for summary judgment on the grounds that absent expert testimony, plaintiffs could not meet their burden of proof. Id. at *2. The court held a Daubert (in NJ Kemp) hearing and heard testimony from both plaintiffs’ and defense experts. In addition, the court requested that the parties provide the court with copies of “all reports, abstracts, epidemiology studies, and peer-reviewed articles” relied on by any of the experts in formulating their opinions.   Id. (emphasis added). That resulted in the court receiving approximately 100 pieces of scientific literature – which the court apparently read and used in analyzing the expert evidence presented. Id. A serious undertaking. One which clearly inured to the benefit of the defense in this case, and frankly a deep dive on the science most often favors the defense. We welcome an informed and educated court. As this court stated at the outset: “Courts are experts in the law, not science.” Id. And juries are experts in neither. Which is why we greatly appreciate a court that takes seriously its role as the crossing guard at the intersection of science and law in the courtroom.

Continue Reading New Jersey – At the Intersection of the Scientific Method and the Rule of Law

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).

Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims

If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.

Continue Reading New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation. The three decisions are: Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background. These three are not mass tort cases. They are examples of what happens when there is indiscriminate plaintiff-side advertising. People call up these 800 numbers because they had “mesh” implanted. They don’t have the targeted product but – what the hey? – it’s mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike. So we’ll concentrate on the Goodson opinion – if for no other reason than alphabetical order.

Continue Reading New Jersey Mesh Summary Judgment Hat Trick